zanidatamab
Embryo-Fetal Toxicity
Based on the mechanism of action, zanidatamab can cause fetal harm when administered to a pregnant woman. There are no human or animal data on the use of zanidatamab in pregnancy. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
Patient care
Verify the pregnancy status of females of reproductive potential prior to the initiation of zanidatamab. Advise pregnant women and females of reproductive potential that exposure to zanidatamab during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception while receiving zanidatamab and for 4 months following the last dose of zanidatamab.